Better Antibodies By Design - Jefferies London Healthcare Conference November 15, 2017 - Genmab
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Forward Looking Statement This presentation contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to our products), are forward looking statements. Such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward looking statements. Such forward looking statements are based on numerous assumptions regarding our present and future business strategies and the environment in which we will operate in the future. The important factors that could cause our actual results, performance or achievements to differ materially from those in the forward looking statements include, among others, risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of our products in patients, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. Further, certain forward looking statements are based upon assumptions of future events which may not prove to be accurate. The forward looking statements in this document speak only as at the date of this presentation. 2
Genmab At-A-Glance Vision: By 2025, our own product has transformed cancer treatment and we have a pipeline of knock-your-socks off antibodies DARZALEX® Tisotumab vedotin DuoBody® Platform Solid financial Arzerra® HuMax®-AXL-ADC HexaBody® Tech. base 2 marketed products 2 exciting proprietary 2 proprietary next Aim to own at least generating royalty clinical programs gen. technologies for 50% of product rights income robust pre-clinical Allows for building pipeline capabilities to market own product in future 3
Antibody Innovation Powerhouse Creating Value for Stakeholders Antibody expertise Innovation engine DuoBody platform HexaBody platform Strategic collaborations 4
Innovative Clinical & Pre-clinical Pipeline Further Development for Marketed Products Product Disease Indications Development Phase Pre- I I/II II III Clinical Daratumumab BTD (2 - MM) Multiple myeloma (MM) Target: CD38 Partner: Janssen Amyloidosis Natural Killer /T-Cell Lymphoma (NKTCL), Nasal Type Myelodysplastic Syndromes (MDS) Solid tumors Ofatumumab BTD (CLL) Follicular lymphoma (FL) Target: CD20 Indication: Cancer Partner: Novartis Ofatumumab (OMB157) Relapsing multiple sclerosis Target: CD20 (RMS) (SubQ) Indication: AI Partner: Novartis 5
Innovative Clinical & Pre-clinical Pipeline Product Disease Indications Development Phase Pre- I I/II II III Clinical Tisotumab vedotin Solid cancers Target: TF HuMax-AXL-ADC Solid cancers Target: AXL Teprotumumab (RV001) BTD Graves’ orbitopathy Target: IGF-1R, Partner: Horizon Pharma AMG 714 Celiac Disease Target: IL-15, Partner: Celimmune ADCT-301 (HuMax-TAC-ADC) Lymphoma Target: CD25, Partner: ADCT Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) JNJ-61186372 Non-small-cell lung cancer Targets: EGFR, cMet, Partner: Janssen (NSCLC) JNJ-63709178 Acute Myeloid Leukemia (AML) Targets: CD3, CD123, Partner: Janssen JNJ-64007957 Relapsed or refractory MM Targets: BCMA, CD3, Partner: Janssen >20 Active Pre-clinical programs incl. Proprietary programs: HuMab, HexaBody-DR5/DR5, DuoBody HuMab-ADC, DuoBody, DuoBody- CD3xCD20 ADC & HexaBody Partnered programs: HuMab, 6 DuoBody & HexaBody
Daratumumab (Marketed as DARZALEX®) Approved in US & EU First-in-class antibody targeting CD38 – 2 FDA BTDs Marketed as monotherapy in US & EU for double refractory MM Approved in US, EU & Japan in combo. w/ Revlimid & dex or Velcade & dex for relapsed / refractory MM Approved in the US in combo. w/ Pomalyst & dex for pts w/ MM who have received at least 2 prior therapies Industry sponsored clinical studies ongoing in MM, NKT-cell lymphoma, MDS, amyloidosis and solid tumors Blockbuster potential – growing royalty income Royalty rate: 12% - 20% Collaboration w/ Janssen Biotech Up to $1bn in dev., reg. & sales milestones, Janssen responsible for all costs assoc. w/ dev. & commercialization 7
Expansive Daratumumab Clinical Development: MM Disease Stage Therapy Development Phase No. Pre- I I/II II III Pts Clinical High Risk Smoldering Subcutaneous 360 AQUILA Monotherapy 126 CENTAURUS Front line (transplant & non- transplant) Dara + VMP Dara + VMP (Asia Pacific) 706 ALCYONE 192 Dara + Rd 744 MAIA Dara + VTd Dara + RVd 1,080 CASSIOPEIA GRIFFIN 216 Multi combo study (6 arms) 250 EQUULEUS Relapsed or Refractory Dara + Vd (China) 210 Dara + Kd 450 CANDOR Dara + Pom + d 302 APOLLO Subcutaneous vs IV 480 COLUMBA Dara + Imfinzi* 264 FUSION Dara + Keytruda 57 V = bortezomib , MP = melphalan- prednisone , T = thalidomide , d= Dara + Venclexta + d +/- V 90 dexamethasone, R = lenalidomide, K = Kyprolis, Pom = Pomalyst Fully recruited *Trials on partial clinical Dara + Opdivo* 375 hold, unrelated to daratumumab Maintenance integrated into some study protocols Dara + Tecentriq* 288 8 Select Studies
Expansive Daratumumab Clinical Development Other Indications Disease Stage Therapy Development Phase No. Pts Pre-Clinical I I/II II III Amyloidosis Dara SC + CyBorD 370 ANDROMEDA NKTCL (nasal type) Monotherapy 32 VOLANS Colon cancer Dara + Opdivo 340 MDS Dara or talacotuzumab 31 NSCLC Dara + Tecentriq 96 CALLISTO NSCLC, pancreatic, Dara + Opdivo triple neg. breast 120 cancers Virus associated Dara + Opdivo 500 tumors 9 CyBorD = cyclophosphamide, bortezomib and dexamethasone
Ofatumumab (Arzerra®) Human antibody targeting CD20 Two Phase III studies in relapsing MS ongoing MS Advantages: Dosing Better disease management, subcutaneous dosing MS Advantages: Attributes Potential for low immunogenicity, manageable safety profile Marketed in various territories for certain CLL indications* Collaboration with Novartis Cash flow positive for Genmab 10 *See local country prescribing information for precise indications
Clinical Projects: Tisotumab vedotin Phase I/II studies in Patients with Solid Tumors Fully human antibody-drug conjugate (ADC) Targets Tissue Factor (TF) Therapeutic potential in broad range of solid tumors Studies ongoing in solid tumors Indications incl. gynecologic (ovarian, cervical, and endometrial) cancers, prostate, bladder, & esophageal cancers, NSCLC & SCCHN Encouraging preliminary safety & efficacy data Promising data in pts w/ cervical cancer Based on data, looking at further dev. in indication Co-development with Seattle Genetics 11
Clinical Projects: HuMax-AXL-ADC Efficacy in in vivo Tumor Model Human ADC Targets tumor-associated AXL Therapeutic potential in solid tumors First-in-human Phase I/II study Indications incl. gynecologic (ovarian, cervical, & endometrial) cancers, thyroid cancer, NSCLC and melanoma ADC technology licensed from Seattle Genetics 12 Malignant Melanoma: AXL expression indicated by brown staining
Next in the Clinic: 2017 IND Candidates HexaBody-DR5/DR5 DuoBody CD3xCD20 • Targets DR5 for cancer • Humanized IgG1 bispecific therapy antibody • Potentially effective in multiple • Activates T cells to kill CD20+ tumor types tumor cells DR5 activation induces cell death 13
Genmab Proprietary Innovative Pipeline Potential INDs in next 4 years Technology product 2017 2018 2019 2020 HexaBody HexaBody‐DR5/DR5 DuoBody DuoBody‐CD3xCD20 HexaBody DuoHexaBody DuoBody DuoBody‐CD3xX Immuno‐Oncology DuoBody‐A [>10 progr.]* DuoBody‐B DuoBody‐C DuoBody‐D *: Aduro Biotech & BioNTech DuoBody‐E Pre-clinical pipeline targeting at least 4 leapfrog INDs in next 4 years 14
Cutting Edge Capabilities: Proprietary Technologies to create Leapfrog Drugs DuoBody • Efficient & versatile bispecific Ab platform • Applicable to any antibody from any platform • Regular IgG format • Large scale production validated • No developability liabilities • Robotized bispecific library generation • Multiple ongoing collaborations incl. with Novartis, Novo Nordisk, Gilead & Janssen Biotech HexaBody • Robust effector function enhanced Ab • Enables antibodies to readily form clusters of 6 (hexamers) • Induces & enhances target cell killing after binding (CDC and apoptosis) • Creates innovative products in cancer & infectious diseases • Collaborations with Humabs BioMed, Agenus and others 15
Well-Capitalized Biotech – 2017 Guidance 2017 Expense Base Income Statement DKKM USDM* DKK 1,050M ($161M) Revenue 1,950 – 2,150 309 - 341 Operating expenses (1,000) – (1,100) (159) – (174) DKK 159M ($25M) Operating income 900 – 1,100 143 - 174 15% DKK 91M ($14M) Cash position at end DKK 239M 9% >4,500 >714 ($38M) of year** *USD 1.00 = DKK 6.3038 23% **Cash, cash equivalents and marketable securities 2017 Guidance – Nov 8, 2017 DARZALEX sales • Genmab’s estimate of DARZALEX net sales USD 1.1-1.3 billion Revenue mid-point DKK 2,050M 53% • DARZALEX royalties DKK 1,000M • DARZALEX milestones DKK 800M DKK 561M • Quality of revenue improving Expense mid-point DKK 1,050 Project Costs ($89M) • Expense increase DKK 287M, +38% Salaries • Continued investment in our clinical & pre-clinical pipeline • 8 pipeline projects drive ~DKK 440M, 42% of total expense Support Svcs Depr. & Stock Comp. 16
2017 Goals Maximizing Differentiated Product Portfolio Value Priority Targeted Milestone Maximize daratumumab » EMA decision & launch in 2nd line+ in multiple myeloma (MM) progress relapsed / refractory setting » FDA decision in 3rd line MM setting (daratumumab + POM) » Phase III MM interim efficacy analysis in frontline (Alcyone trial) » Start Phase III subcutaneous trial » Start trials in solid tumors and non-MM blood cancers » Report non-MM clinical data Optimize ofatumumab 2018* » Phase III refractory follicular lymphoma headline results value Strengthen differentiated » Phase I/II tisotumab vedotin data product pipeline » Progress HuMax-AXL-ADC Phase I/II clinical trial » IND/CTA submission HexaBody-DR5/DR5 » IND/CTA submission DuoBody-CD3xCD20 » Progress pre-clinical pipeline Broaden partnership » Enter new technology collaborations portfolio with next » Progress partnered programs generation technologies Disciplined financial » Execute controlled company growth with selective investments in management product pipeline 17 *Data read out now expected to occur in 2018.
Creating Value for Patients & Shareholders Building on 3 central pillars: Focus, Innovation & Execution Robust pre-clinical Building commercial 2 marketed products pipeline expertise 2 proprietary early World-class antibody Solid financials stage clin. programs & R&D expertise 2 proprietary Strategic Proven track record technologies collaborations 18
www.genmab.com
You can also read